21 CFR Part 11 - Electronic Signature Certification

W

WilBryan

#11
Dont want to start a new topic with this one already open for discussion. My question is (somewhat) related so i figured this is as good a place as any...

Our company is certified to 9001:2003 & 13485:2008 but we have never done manufacture of a medical device.
We are now currently in the early stages of a possible FDA regulated medical device project. With this in mind and the pending changes to our 13485 registration to meet the new standard, we are looking at various ways to meet the requirements of validation for both product and software contributing to processes or product.
One option that management has presented is to return to paper copies of certain documentation to meet the signature needs. I'm reluctant to take a step backwards and am sure there must be some affordable solutions on the market.
Does anyone have any suggestions of or experience with certificate authority providers, electronic signature software, or other validation methods to meet the FDA requirements (part 11) and similar regulatory requirements for 13485?

Any help or recommendation would be greatly appreciated.
thanks!
w.
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#12
Although we sent in the requisite letter to the FDA sometime ago, I've still been hesitant to implement a universal system.

To be honest, between the overhead of validating software, and sourcing a software solution that meets CFR requirements, and is not too costly to get licenses for each individual, I've found that "return" to paper copies is easiest for now.

Once a revision of an electronic document is ready for review/approval, it is simply printed and signatures collected.

The signed, paper copy is filed as a record of the signatures, but the electronic version is maintained in a read-only format for accessibility.
 
G

Gert Sorensen

#13
One option that management has presented is to return to paper copies of certain documentation to meet the signature needs. I'm reluctant to take a step backwards and am sure there must be some affordable solutions on the market.
That's understandable, and perhaps you wont need to, but you will need to evaluate your systems to see what you actually can do.

Does anyone have any suggestions of or experience with certificate authority providers, electronic signature software, or other validation methods to meet the FDA requirements (part 11) and similar regulatory requirements for 13485?
I am not affiliated, but DocuSign has a really nice product that they acquired from ARX (CoSign) that can be used with a lot of standard software products. Besides that some ERP systems has E-signature capabilities that makes it possible to sign on BOM/BOL and in process and final QC activities.
:bigwave:
 

matkins

Starting to get Involved
#14
When I tried to download the FR from the link to a PDF, I got an error message that the electronic signature was unknown and could not be verified.

Classic!! :lmao:
 
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